Japanese Study With Rimonabant in Obese Type 2 Diabetic Patients on Diet and Exercise (SOLO)

Sanofi

Status and phase: Terminated; Phase 3

Conditions: Diabetes Mellitus Type 2; Obesity

Treatments: Drug: Rimonabant; Other: Diet and exercise; Drug: placebo (for Rimonabant)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00478972

EFC6648

Details and patient eligibility

About

The primary objective of this study is to assess the efficacy of Rimonabant (SR141716) compared to placebo on change in HbA1c and on relative change in body weight over 36 weeks in obese type 2 diabetic patients inadequately controlled with diet and exercise alone.

The secondary objectives are:

• To evaluate the effect of Rimonabant compared to placebo on other parameters related to the glucose control, waist circumference, Body Mass Index and metabolic parameters;
• To evaluate the safety and tolerability of Rimonabant compared to placebo;
• To evaluate the pharmacokinetics of Rimonabant.

Full description

The total duration per patient will be approximately 53 weeks including a 36-week double-blind treatment period.

Enrollment: 321 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 Diabetes Mellitus patients inadequately treated with diet and exercise alone (not drug treated)
• HbA1C ≥ 7.0 % and ≤ 10.0 %
• Body Mass Index ≥ 25 kg/m²

Exclusion criteria

• Type 1 diabetes
• Within 12 weeks prior to screening visit: use of oral antidiabetic drugs and/or insulin, of anti-obesity drugs or other drugs for weight reduction
• Within 4 weeks prior to screening visit: administration of systemic long-acting corticosteroids or prolonged use (more than one week) of other systemic corticosteroids, change in lipid lowering treatment
• Secondary obesity
• Primary hyperlipidemia
• Positive serum pregnancy test in females of childbearing potential

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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321 participants in 2 patient groups, including a placebo group

Rimonabant

Experimental group

Description:

Rimonabant 20 mg once daily in addition to diet and exercise

Treatment:

Other: Diet and exercise

Drug: Rimonabant

Placebo

Placebo Comparator group

Description:

Placebo (for Rimonabant) once daily in addition to diet and exercise

Treatment:

Other: Diet and exercise

Drug: placebo (for Rimonabant)